Executive Director, QA Compliance

Who We Are: Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com , and follow the company on LinkedIn , X , Facebook and YouTube . ( *in collaboration with AbbVie ) At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

 About the Role: Provides strategic leadership and oversight for the Quality Compliance function and is responsible for establishing and maintaining programs that promote sustained regulatory compliance and inspection readiness across Neurocrine's GxP activities. Provides leadership for external and internal audit and compliance programs, inspection readiness, management review, quality risk management, GMP laboratory compliance, recall management, and related compliance initiatives. Serves as a trusted Quality advisor to senior leadership, providing strategic direction on complex compliance matters, emerging regulatory expectations, quality risks, and opportunities for continuous improvement. Partners across Quality and with cross-functional stakeholders to ensure compliance programs are risk-based, effective, scalable, and aligned with Neurocrine's business and development objectives. Leads and develops the Quality Compliance organization, establishes strategic priorities and operating plans, and promotes a strong culture of quality, accountability, continuous improvement, and inspection readiness across the organization. _ Your Contributions (include, but are not limited to):

• Provides strategic leadership and direction for the Quality Compliance function, establishing multi-year strategies, priorities, operating plans, and objectives aligned with broader Quality and company goals
• Leads external audit program and establishes a risk-based audit strategy encompassing GxP vendors and service providers
• Own the supplier/vendor quality management system and associated policies (e.g., aligned to ISO 9001, ISO 13485, GxP, or industry-specific standards)
• Define quality requirements, acceptance criteria, and KPIs for vendor onboarding and ongoing performance
• Establish and maintain vendor quality agreements (VQAs) / quality technical agreements
• Lead supplier qualification, requalification, and risk-based audit programs
• Segment and score vendors by quality/compliance risk criticality
• Maintain business continuity and contingency plans for high-risk/critical suppliers
• Partner with Procurement on risk-informed vendor selection and contract terms
• Conduct or oversee on-site and remote audits (quality systems, manufacturing processes, documentation practices)
• Approve, conditionally approve, or disqualify vendors based on audit findings and risk assessments
• Leads the internal audit program and establishes a risk-based audit strategy encompassing applicable GxP systems and functions, including Drug Safety/Pharmacovigilance, Clinical Operations, GMP laboratories, and other auditable systems
• Provides strategic oversight of the annual internal audit plan, including risk-based prioritization, governance, execution, escalation of significant findings, and monitoring of corrective and preventive actions
• Establishes and maintains an organizational inspection readiness program to ensure ongoing preparedness for regulatory inspections and other external assessments
• Maintain audit-ready documentation and evidence for internal/external inspections
• Monitor regulatory changes and update vendor compliance requirements accordingly
• Manage vendor-related regulatory findings, warning letters, or non-conformance
• Provides leadership and strategic direction during regulatory inspections, including inspection preparation, coordination, response strategy, remediation, and management of inspection commitments, as applicable
• Leads Quality Management Review activities, ensuring senior leadership has appropriate visibility to quality performance, compliance trends, emerging risks, significant quality issues, and effectiveness of compliance programs
• Provides strategic oversight for GMP laboratory compliance and partners with applicable Quality, Technical Operations, and laboratory stakeholders to identify, assess, and mitigate compliance risks
• Leads and continuously improves the Quality risk management framework, including development and oversight of risk assessments and processes for identifying, evaluating, escalating, mitigating, and monitoring significant quality and compliance risks
• Provides strategic oversight of recall management processes and ensures appropriate governance, cross-functional coordination, escalation, and execution of product recall activities, as applicable
• Drives continuous improvement of SOPs, compliance processes, tools, and governance mechanisms based on regulatory expectations, inspection and audit trends, business needs, and identified risks
• Establishes meaningful compliance metrics, dashboards, and key performance indicators to monitor organizational compliance, identify trends, and inform risk-based decision making and management review
• Provides governance and strategic oversight for Quality Compliance data and systems, including applicable Veeva organizations, risk classifications, supplier categories, audit certifications, questionnaires, and related compliance information
• Ensures risk classifications, compliance questionnaires, and other compliance assessment tools are periodically reviewed and updated to reflect evolving regulatory requirements and business needs
• Serves as a senior Quality Compliance advisor to Quality leadership and cross-functional stakeholders on complex or high-risk compliance matters
• Interprets emerging regulatory requirements and industry trends and assesses their potential impact to Neurocrine's Quality operations and compliance strategy
• Partners across Quality and with Clinical Operations, Drug Safety/Pharmacovigilance, Technical Operations, Regulatory Affairs, R&D, and other functions to drive integrated and sustainable compliance solutions
• Promotes organizational awareness of quality and compliance expectations through effective communication, education, and compliance-related communications and initiatives
• Develops, leads, mentors, and retains a high-performing Quality Compliance organization; establishes clear expectations and accountability while building organizational capability and succession readiness
• Provides leadership through subordinate leaders and/or high-level professionals and effectively manages resources, priorities, and organizational capabilities required to achieve Quality Compliance objectives
• Champions a culture of quality, integrity, accountability, risk-based decision making, continuous impr